Briefs

A New Drug Safety Database for Pharma, FDA

By Mark D. Uehling, Bio-IT World

(05/03/05) You're an insurance company. You've got data on the
prescriptions, general health, and laboratory tests of 11 million
Americans. You've already used that data to reduce your own costs
related to prescription drugs. What to do? Why, sell your data to
pharma, naturally.

That's the strategy of a subsidiary of UnitedHealth Group called i3
Research, which later this year hopes to sell its de-identified,
HIPAA-compliant data to the FDA and the industry.

The i3 objective: monitor drug safety issues in ordinary patients after a drug's approval, far from the tightly controlled realm of clinical trials in which most patients take just a single medication. Thus i3's database will monitor real-world patients, and thereby supplement the black art of determining which medications are working as expected – and which are triggering broad patterns of side effects across the population.

...

Because i3's database includes concomitant medications and other
clinical information, it's already clear that meaty, national
epidemiological questions could be explored. In its data-mining
techniques, Tramuto says, i3 is combining its own proprietary
algorithms and software from third-party vendors; the company intends
to provide the sharpest possible tools to customers. ...